2. Consolidating Clinical Trial Management, Mobility, and Monitoring in the Cloud
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James Streeter
Senior Director Life Sciences Product Strategy
HSGBU
October 1, 2014
Copyright © 2014, Oracle and/or its affiliates. All rights reserved. |

3. Safe harbor statement.

4. Strategy Life Sciences Healthcare Convergence
Accelerate clinical development
Support entire drug safety lifecycle
Enable clinical data aggregation
Power enterprise healthcare analytics
Enable provider/payer integration
Drive personalized medicine
Intersection of clinical trials and clinical care
Develop collaboration networks for providers and life sciences companies
The Oracle Health Sciences Strategy is actually pretty simple
We recognize that our customers are at different points of the spectrum when it comes to the convergence of life sciences and healthcare
We’re helping our customers maximize their capabilities at every stage and we are at the forefront of the accelerating convergence wave
I’ll be talking more about our innovation in life sciences but it’s important to know we are leaders in the healthcare arena as well
-For example our translational research and enterprise healthcare analytics solutions are powering the Moon Shots program at MD Anderson Cancer Center…UPMC’s aggregation of clinical, genomic, financial, administrative, and operational data from over 200 different sources…and the Mayo Clinic’s single infrastructure for storage, integration, and management of all their genomic data

5. Clinical Research and Development Solutions Delivering End-to-End Value
Oracle delivers advanced transformative value for clinical R&D in a modular, integrated and scalable cloud environment and helps you:
Optimize Operations
With technology that helps you maximize
efficiency across your clinical life cycle
Innovate
By incorporating genomics, biomarkers
and real-world patient data
Future-Proof your Business
With a platform that evolves and grows with you and the industry
Gain Actionable Insights
From aggregated clinical
and healthcare data
-What are some of the ways we do that?
-We continually develop pragmatic yet innovative solutions that optimize and fundamentally improve the current landscape of clinical R&D, such as activity-based planning, mobile monitoring, and direct patient-to-EDC data capture through digital sensors
-Our strengths in data management and our ability to bring the data together and accessible to our comprehensive analysis tools drive better insights and decision- making
-We are facilitating the collection and use of genomic and healthcare data in clinical trials to conduct more effective trials and derive improved outcomes and safety monitoring
-Finally, Oracle Health Sciences’ significant and ongoing commitment to research and development, and the breadth of our platform, provides a level of innovation and support that ensures you will have a partner for the long term to grow with you as our industry evolves

6. Clinical R&D Platform : Pipeline to Patient
Optimized and integrated processes across the clinical development landscape
Study Connect
Identity Access Mgt
Planning
Workflow, Clinical Data Model, MDM, MDR, CDR, Analysis
LSW CLOUD
CDA Trial Analyzer
Risk-Based Monitoring Planning and Simulation
CDA Cloud
Clinical Performance Benchmarks
IRT
Trial Supply Mgt. Forecasting
Plan Track Source
ClearTrial
Investigator Network/Portal
Grants Forecast
CRO
Site Quality
Metrics
Third Party
Data Sources
Trial Initiation
HSN
Pt Recruit
Protocol Validation
Study Start-Up and Design
Protocol Collaboration
Trial Initiation
Third Party
Study Design Tools
Trial Conduct
IRT (RTSM)
Argus
CTMS
Monitoring Cloud
Data Capture & Data Mgt
InForm
OC RDC / TMS (Hosted)
Site Reimbursement
Payments Analytics
CDA
InForm / Central Designer
InForm Medical Adherence Insights
Medical Imaging
End Point Adjudication
Mobile CRA
InForm Utilities
CRF Submit
InForm Molecular Analytics
eTMF
Submission/ Analysis
eCTD Gateway
Standards Gateway
LSH / DMW / SCE
LSW Cloud
Post-Marketing
EHR (HSN)
eCOA / MHealth
InForm Late Phase
CTMS Cloud/ Call Centre
OMICS Databank
Patient Device M2M Networks
LSW Cloud
Argus
Empirica
Via Integrated Technology Partners

7. Oracle Delivers the Most Advanced and Easy-to-Use Closed-loop Clinical Trial Management Offering
Plan
Oracle ClearTrial
Builds study plans based on actual study activities
Forecasts and budget resources, costs, units and timelines
Source
Optimizes allocation of resources using simulations
Consolidates projects on portfolio level
Helps negotiate and manage RFPs and contracts
Execute
Oracle CTMS, Oracle IRT
Designs, codes and randomizes trials
Manages clinical trial execution
Capture Data
Oracle Inform and OC/RDC
Captures clinical trial data electronically
Aggregates and maintains clinical trial data centrally
Analyzes clinical trial operations and outcome data
Track
Tracks project status and accruals
Assesses strategy and automatically re-forecasts
Pay
Oracle Financials, Oracle PeopleSoft Financials
Makes payments from financial systems
Improve
Analyze
Source
Execute
Plan
Capture Data
Track
Pay

8. Oracle Health Sciences Clinical Monitoring Suite
Purpose-Built Solution for Today’s Complex Trial Environment
Data Warehousing—Clinical Data Integration, Validation, and Cleansing Oracle Health Sciences Data Management Workbench
Trial Management
Siebel Clinical Trials Management System
Contacts Management and Collaboration
Siebel Base CRM for Clinical Trials Management
Site Monitoring Visits
Oracle Health Sciences Mobile CRA
Tablet-based Trip Reporting (Disconnected support)
Site Check-in for Compliance
Analytics and Reporting
Oracle Health Sciences Clinical Development Analytics
Finance and Investigator Payments
Siebel CTMS Payments
Investigator Payments PIP
Adaptive Monitoring
Siebel CTMS
Clinical Development Analytics
Mobile CRA
HSGBU Data Management Suites
Safety Data and Reporting Oracle Argus Safety & Empirica Tools
Data Management and Collection Oracle Health Sciences InForm GTM Suite
Oracle Clinical / Remote Data Capture
Clinical Trials Management System
Proven Scalability
Multilingual Support
Business Intelligence
Clinical Process Automation
Complex Trial Support
Open UI
Interoperability and Integration
Siebel Enterprise Application Integration
Prebuilt integrations to HSGBU Suite
Document Server
MS-Office, Outlook Calendar integration
Mail Merge
Trial Planning and Forecasting
Oracle Health Sciences ClearTrial

9. Clinical Monitoring Cloud Offering(
User Access SSO IDM
Monitoring Cloud
CTMS: Industry leading solution with new Open UI interface
CDA: Analytical insights to support faster decision-making
Support: Tier I and Tier II support
via HSGBU and Product Support
Mobile CRA: Study awareness and streamlined site visits via mobility
Clinical R&D Cloud
Manage: Application Monitoring, DR, Lifecycle

10. CTMS

11. What’s New: Oracle Clinical Operations Cloud Service
Unlock the Full Value of Your Investment
Clinical R&D Cloud
Accelerated Implementations
Better Compliance at Lower Cost
Lower TCO and Infrastructure Costs
Improved Processes and Controls
Proactive Patches and Updates
Reduce IT Management Time and Effort
Reduced Upgrade Risk and Downtime
Far Fewer Average Service Requests
World-Class Security and Compliance
Ready-To-Go Environments for faster time to value
Accelerators to leverage industry best practices
Anywhere, Anytime Availability via Web
24x7 Support
Oracle Cloud Services customers realize significant, measurable benefits and business value.
MORE VALUE.
MORE CHOICE.
MORE CONFIDENCE.

12. We always leverage our vast CTMS collateral
Leverage our industry library of CTMS requirements and processes
A large library of pre-built Siebel CTMS processes
Maintain a library of out of the box and pre-configured CTMS functionality to guide workshops
Utilize a Virtual Prototyping Environment to accelerate requirements and design sessions
Access to our library of CTMS implementation artifacts

13. CTMS Accelerators leverage industry best practices to speed time to value
Based on Leading Practices for:
Pre-built CTMS Process Flows and Accelerator Configurations
Document Management
Trip Reporting
Investigator Candidate Identification and Assessments
Study Setup
Protocol Authoring and Approval
Informed Consent, Investigator Brochure and Subject Materials Preparation
CRF Design
Subject Visit Template Setup
Select and Initiate Partners for Study
Site Selection
Monitoring/Site Evaluation
Randomization Request and Fulfillment
Site Initiation Package
Screening and Enrollment Tracking
Screening and Enrollment – IVRS
Monitoring – Site Initiation
Monitoring - Interim Monitoring
Monitoring – Closeout
Clinical Supplies Planning
Each Package includes:
Pre-configuration Install File
High Level Design Specification
Functional Requirement
Design Approach
Step-by-Step Installation and System Testing instructions

14. Modernize with Siebel Open UI / Siebel Mobile
Enhanced User Experience: Maximize productivity
Any Browser: Flexible deployment
Templates: Create your own user experiences quickly
Any Device: Choose your platform with automatic device rendering
Coexist: Leverage existing Siebel investments
Advanced Standards: Tailor readily with common tech skills
Simplified Integration: Reduce total cost of ownership

15. Open UI Customization Possibilities
Themes: style for familiarity or brand
Customer Dashboard: View top information on a single screen
Industries: plan, perform, and track field sales and service activities
Web Self-Service: empower customer self help

16. Mobile: Native look and feel
“Designed for Mobile”
Device driven rendering; Infinite scrolling
Integration with native Phone, PIM, location based integration
Multi-touch gesturing (mobile) and HTML5
Offline mode with synchronization (TBD)

17. Use Case: How We Support Risk-Based Monitoring
Adaptive Monitoring
Use Case: How We Support Risk-Based Monitoring
Following FDA, EMA, TransCelerate
Quality by Design (QbD): Risk-based trial planning and impact simulation
Quality Mgt Indicators
Compliance Indicators
Performance indicators
Predictive risk simulations
Clinical Data Analytics
Subject Safety
Compliance & Performance
Data
Integrity
Protocol Deviations
Data Entry & Approval
Data Cleanliness
Follow Up Items
Site Visit Frequency
Screen Failure Rate
Subject Withdrawal Rate
TMF Compliance
Clinical Supplies
SDV
Enrollment Rate
Subject Visits Out of Window
Visit Report Contents
Historical Clinical Data
SAEs
Current Clinical Data
Historical Site Performance
Historical Investigator Performance
AEs
EDC
OC/RDC & InForm
Quality by Design (QbD)
Source Data Verification (SDV)
Source Data Review (SDR)
CTMS
Siebel Clinical/CDA/MCRA
SDR: quality & compliance
Offsite/central monitoring
Investigator quality and qualitative performance
Mobility
Mobile CRA
SDV
SDR (protocol compliance, site processes, documentation quality)
Risk and Quality controls
Safety
Argus/Empirica
Risk Scores/Indicators
Risk-based inspections
Signal Detection Analysis
GOAL: Enable Life Sciences customers to deploy Centralized and Risk-Based Monitoring Strategies

18. Transcelerate & CDA Risk Category Mappings
Indicator
Analytical & Reporting Marts
Clinical Transactional Applications
Category
Clinical Development Analytics (CDA)
Argus Analytics
CTMS
EDC Inform & OC/RDC
Empirica
Argus Safety
IRT
Safety X
Investigational Product
Subject Recruitment and Discontinuation
Management
General Issues
Data Quality
CRF Completion
Discrepancy Management
On-site Workload-Based Triggers
Essential Documents
Staffing, Facilities, and Supplies

19. Risk-Based Monitoring Oracle’s Multi-System Holistic Approach
Clinical Dashboards & Reports
Access, Planning, &
Collaboration
Mobile CRA
Mobile
ClearTrial
Planning
Customer Portal
Analytics
Clinical Development Analytics
Argus Analytics
Analytics, Insight, & Content Mgmt
Risk Analysis
Signal and Risk Management
Empirica Study
Empirica Topics
Warehouse
Life Sciences Data Hub
Clinical Warehouse & Data Marts
InForm
EDC
OC/RDC
External 3rd Party Data, Programs
Source Data
& Systems
Argus
Safety
Trials Management
Siebel CTMS
Suite Integration & Open Interfaces

20. Risk-Based Monitoring Oracle’s Multi-System Holistic Approach
Provide continuous monitoring of study and site data
Support multiple methodologies for streamlining site monitoring through targeted SDV
Single global safety repository ensuring risk monitoring of subject safety
Access to historical quantitative and qualitative site and investigator performance;
Drive down costs leveraging Oracle’s pre-built integrations and open interfaces to enable RBM Plans
Extensibility to incorporate data and programs from customer applications in the clinical ecosystem (e.g. EDC, CTMS, Lab, ePro, eTMF, etc.)
Over 90% OOTB coverage of risk indicators identified in TransCelerate position paper
Incorporating customer specific systems and processes via open interfaces
Enabling real-time access to actionable insights for decision making through Mobility
Upfront risk based trial planning via ClearTrial
By leveraging existing investments and Oracle technology to drive down costs
GOAL: Enable Life Sciences customers to deploy Centralized and Risk Based Monitoring Strategies
Siebel CTMS
Suite Integration & Open Interfaces
External 3rd Party Data, Programs
InForm
Argus
OC/RDC
Life Sciences Data Hub
Empirica Study
Empirica Topics
Risk Analysis
Argus Analytics
Clinical Development Analytics
Customer Portal
Mobile CRA
Clinical Dashboards & Reports
ClearTrial
While ensuring data integrity, subject safety and compliance

21. Clinical Development Analytics

22. Enabling Operational Performance Management from Sites to Execs
ORACLE CLINICAL
DEVELOPMENT ANALYTICS
Executive
Team
Organizational
Progress
Head of Clinical
Operations
Departmental /
Regional
Progress
CRA /
Data Manager
Study
Progress
Clinical Sites
Site
Progress

23. Cloud-Based Delivery of Site Performance and Risk Analysis
• Users access information and analytics through role-based dashboards
• Can also publish reports to PDF, distribute, or access through MS Office
Clinical R&D Cloud

24. CDA’s Interactive Reports Provide Actionable Clinical Insight
Business
Objectives/
Issues
Accelerate Enrollment
Is Program on target?
Drill to Detail
Which studies
are behind?
Gain
Insights
Which sites are
slowest recruiters?
Drill to Site Detail
Take Action
Call Site to Understand
Low Enrollment 24 24

25. Event-Driven Clinical Insights via Alerts and Reports
Business
Objectives/
Issues
Maximize Data Quality
New Site Coordinator mid-study (site turnover)
Event logged on Exception Report
Risk
Identified
Study Manager reviews exceptions daily
Visit Schedule for site is updated with new site visit
Take Action
SDV Plan updated for study site (e.g. 100% for next 5 subjects) 25 25

26. Mobile CRA

27. Mobile CRA Vision Briefcase Support View SOP’s Annotation & Bookmarks
Device Integrations
Notification & Offline support
GPS/Location capture for Trip Report
Native contacts listing and Calendar
EDC
View of Source Data available for visit
Summary of Source Data Verified in Trip Report
Mobile CRA
EDC
CDA
CTMS
Gamif-ication
Argus
Open Alerts/SaaG
Voice
Briefcase
Briefcase Support
View SOP’s
Annotation & Bookmarks
Site Compliance
Clinical Development Analytics
Site Metrics
Alerts
Voice Notes & Voice Translation
Speech to Text for Trip Report Notes
CTMS
Trip Report
Contacts and Site information
Calendar
Open Alerts & SaaG
Integration with 3rd party External & Internal system
Safety
Serious Adverse Event review and verification 27 27

28. Mobile CRA Mobilizing Clinical Trial Monitoring Site-At-A-Glance
Provides study site focused performance indicators in a single view so CRAs have up-to-date site progress information at their fingertips, enabling more efficient, proactive planning and more productive site visits
Study Alerts and Notifications
Alerts CRAs of key milestones, activities and potential issues for the study sites they are monitoring, enabling them to respond quickly to potential issues that may affect key milestones for the overall study
Tablet-based Trip Reporting
Revolutionizes trip reporting with the ability to download, complete and upload trip reports through a lightweight, intuitive role-focused app on a mobile tablet
CTMS Contacts Synchronization
Makes available up-to-date site contact information maintained in your global clinical database so that communication with site via phone, , or travel is faster and easier

29. Mobile CRA Simplifying Site Visits
Simplified Monitoring for Traveling CRAs
Provides more efficient workflows for upfront planning, on-site execution and final closeout activities of site visits while facilitating compliance to industry guidance and best practices
Study Site Check-In
Captures site check-in details of traveling CRAs for each site visit to be stored on the trip report so compliance to site monitoring requirements can be demonstrated via geo-location information captured while onsite
Native Mobile App
Provides an optimum end-user experience benefiting from native capabilities of mobile devices, e.g. GPS, Contacts integration, Messaging, etc.

30. Clinical Monitoring Suite
CDA 3.X
Sourcing un-sourced Measures
Enhancements of Risk-Based Monitoring
Additional measures from CTMS/EDC
Action Framework for supporting actions back to source systems
New Monitoring Dashboards/Reports - User driven thresholds at Study, Project, Indication, TA
Mobile CRA 2.0
Inline InForm SDV
Single, unified interface for field monitors
Automated SDV tracking and update to Trip Report
Nuance Voice Recognition
IAMS integration
Clinical Monitoring Suite
ClinOps Cloud Suite Offering
New subscription-based model for CTMS / CDA / Mobile CRA offering hosted in the Oracle Cloud
CTMS FP
Web Services to support retrieval of protocol, site, and site visit information
Capture of geo-location related to Mobile CRA
CTMS FP
Open UI Certification
Fresh, Modern UI
Browser Independence
Support for Standards
Mobility Support
Mobile CRA 1.X
Android Device Support
- Phone, Phablet, Tablet
2012
2013
2014
CTMS 2012-IP
Complex Trials / Trip Report Workflow
Support multi-arm flexible trial design
Trip Report Enhancements
Reviewer/Approver fields & status
New State Model
New Layout / Approvals / Audit Trail views
Add’l Integration Objects
CDA 2.2
Enabling Comprehensive and Detailed Insight Milestone & cycle time performance management
Key performance indicators & targets at multiple levels
New executive and region-level dashboards
Around 50 new pre-built reports and 33 new dashboard pages
Mobile CRA 1.0
Guided Site Monitoring
Study Progression Awareness,
Streamlined Site Collaboration
CTMS 2013-IP
Trip Report Simplification
Data Driven Trip Reports
Configurable on the fly
Real-time response branching
Comprehensive feedback for trip report review
Payment Enhancements
Split payments
Multiple Payees
Revert payments
VAT support
CDA 3.0
Support for Sourcing InForm Studies
InForm 4.6 or later as a transactional source
DM Metrics aggregated by Region
Mobile CRA 1.2
Open SaaG / Alerts
Configurable Site-at-a-Glance
Open Site-At-A-Glance
Open Alerts
CTMS 2014-x
Risk-Based Monitoring
SDV Plans and Policies
Site Assessment - New Site Assessment fields - Support new interfaces
New RBM fields (driven by TransCelerate)
Integrations - InForm - ClearTrial
CDA 3.1
Oracle Data Integrator (ODI) Support for ETL in addition to Informatica
Move to ODI for CDA Cloud
Support for ODI and Informatica on-premise
Top Add’l Clinical Monitoring Suite Candidates in and into 2015
Study Risk Simulation Tool
Support risk simulation and what- if scenarios providing scores by risk category based upon historical data during the upfront planning and course of a clinical trial
ClinOps Cloud Suite Refresh (CTMS 2013 / CDA 3.0 / MCRA 1.3 with InForm and IAMS integration)
Product Integrations - ClinOps Suite to IAMS - CTMS to QUMAS - CTMS to GreenPhire - CTMS to Financials - CDA to ClearTrial - Mobile CRA to Nuance - Mobile CRA to InForm

31. 31